A flexible multi use post operative prosthetic socket system

ABSTRACT

A prosthetic apparatus and system for a trans-tibial amputee consisting of a post-operative interface socket that can be adjusted to accommodate the size of an amputated limb and changes in size of the limb. The prosthetic apparatus includes a lower socket into which the post-operative socket can be inserted, the lower socket being adjustable for changes in size of the post-operative interface socket. The post-operative socket also has a removable upper back shell that immobilizes movement of the knee during an initial recovery phase but can be removed to allow the knee of the amputee to flex.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional of application Ser. No. 16/486,301entitled A FLEXIBLE MULTI USE POST OPERATIVE PROSTHETIC SOCKET SYSTEMwhich is a U.S. National Stage Application filed on Aug. 15, 2019, whichclaims the benefit of and priority under 35 USC 371 of InternationalPatent Application PCT/US2018/055155 entitled A FLEXIBLE MULTI USE POSTOPERATIVE PROSTHETIC SOCKET SYSTEM, filed on Oct. 10, 2018 which claimsthe benefit of and priority under the applicable laws of the UnitedStates of: U.S. Provisional Applications Ser. No. 62/696,043 filed onJul. 10, 2018 entitled A FLEXIBLE MULTI USE POST OPERATIVE PROSTHETICSOCKET SYSTEM; U.S. Provisional Applications Ser. No. 62/667,817 filedon May 7, 2018 entitled A FLEXIBLE MULTI USE POST OPERATIVE PROSTHETICSOCKET SYSTEM; U.S. Provisional Applications Ser. No. 62/636,542 filedon Feb. 28, 2018 entitled A FLEXIBLE MULTI USE POST OPERATIVE PROSTHETICSOCKET SYSTEM; and U.S. Provisional Applications Ser. No. 62/570,731filed on Oct. 11, 2017 entitled A FLEXIBLE MULTI USE POST OPERATIVEPROSTHETIC SOCKET SYSTEM the contents of all four of which are reliedupon and incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION Technical Field

The disclosure relates generally to a system and apparatus forpost-operative prosthetic devices for leg amputees and more particularlyfor trans-tibial amputees.

Background Information

The present invention is an improvement over the inventions described inU.S. Pat. No. 5,571,209 for a “Post-Operative Protective Prosthesis”(the '209 patent) and U.S. Pat. No. 5,728,165 for an “AdjustablePost-Operative Prosthetic System,” (the '165 patent). Both patents—the'209 patent and the '165 patent--are incorporated herein by reference asif set forth herein at length. The '209 discloses a post-operativeadjustable protective socket for a patient that has undergone atrans-tibial amputation. The '165 patent added an outer socket 110 (FIG.3 of the '165 patent), a pylon 126, and prosthetic foot. Thus, thepost-operative protective socket 10 could be inserted into the outersocket with pylon and prosthetic foot attached to allow the amputee tostand and walk.

The post-operative preparatory socket 10 is designed with a rear shell13. As stated in the '165 patent, “The rear shell 13 is brought to ahigher elevation so it passes over the wearer's knee and covers aportion of the wearer's thigh above the knee.” (Lines 2 to 4 of the '165patent). Preparatory Socket 10 was designed to immobilize the kneeduring the initial recovery of the amputee. Movement of the knee afterthe operation before it has sufficient time to heat could result in areopening of the wound and other complications.

The '165 patent further states: [0006] After additional healing hasoccurred and the amputation is ready for full weight bearing, thepatient will no longer need the post-operative preparatory socket 10.Instead, a supra patellar socket 210 is indicated (FIG. 2). (Column 5,lines 37 to 40) The supra patellar socket 210 was designed to allow theknee to flex for full mobility when inserted into outer socket 110 withpylon 126 and prosthetic foot 130.

Although unique and very functional, the system described by the '209and '165 patents still required three different sockets. Additionally,to accommodate a wide spectrum of limb sizes of amputees at least 5different sizes of post-operative protective sockets 10 and suprapatellar sockets 210 were needed. This is due to the limitation ofadjustability of the sockets 10 and 210.

No admission is made that any reference cited herein constitutes priorart. Applicant expressly reserves the right to challenge the accuracyand pertinence of any cited documents.

SUMMARY OF THE INVENTION

Among the objectives of the present invention is to provide anadjustable prosthetic system for an amputee that can be adjusted forchanges in the size and condition of an amputee's limb duringpost-operative recovery and rehabilitation.

It is an objective of the present invention to provide an interfacesocket that can initially restrict movement of the leg of the amputeeduring post-operative recovery and then can be modified to allowmovement of the amputee's knee joint.

It is an objective of the present invention to reduce the number ofsockets needed to accommodate the varying leg sizes of amputees.

It is an objective of the present invention to provide a prostheticsystem that can be modified and adjusted to meet the changing needs of apost-operative amputee during the recovery and physical therapy stageswithout the need to provide more than one set of sockets.

The invention accomplishes the above objectives and other objectives byproviding an interface socket for a trans-tibial amputee having: a) abase cup; b) a lower back shell attached to the base cup by a flexibleback strut; c) an upper back shell connected to a top edge of the lowerback shell; d) a front shell connected to the base cup by a flexiblefront strut; e) wherein the interface socket is made of a flexible,resilient and formable material; and f) wherein the front shell and thelower back shell with the upper back shell attached are positioned toform a space there between to receive a limb of a trans-tibial amputeeand be adjusted to vary the space there between to hold and grip thelimb in a secure and comfortable fashion.

In another aspect of the interface socket the upper back shell isdetachably connected to a top edge of the lower back shell and thus theupper back shell can be removed to allow the amputee to flex a knee ofthe amputated limb. In a further aspect of the interface socket of claim2 wherein the detachable connection is selected from a group consistingof a) a super condylar super patellar trim line, b) a supra condylartrim line, and c) patellar tendon bearing trim line.

In a further aspect of the invention the interface socket: a) a firstend of the back strut connects to the lower back shell at a point abovea bottom edge of the lower back shell with a first set of open endedslots on either side of the back strut which slots open at the bottomedge of the Lower back shell and terminate at their opposite closed endwhere the first end of the strut connects to the lower back shell; b) asecond end of the back strut connects to a bottom of the base cup with asecond set of open ended slots on either side of the back strut, thesecond set of open ended slots are open at a rim of the base cup andterminate at a closed end adjacent to the connection of the second endto the bottom of the base of the cup; c) wherein the back strut has abend in it that positions a plane formed by the base of the base cupapproximately perpendicular to a plane formed by a line up a middle ofthe lower back shell; and d) wherein the structure allows the lower backshell to be moved in relation to the front sell to vary the spacebetween the lower back shell and the front shell.

In a further aspect of the invention: a) the flexible front strut of theinterface socket connects at a first end to a portion of a rim of thebase cup opposite a bottom edge of the front shell; b) the flexiblefront strut of the interface socket connects at a second end to aportion of a bottom of the front shell with open ended slots on eitherside of the strut to thereby create a bottom edge of the front shellseparated from and opposite from a portion of the rim of the base cup oneither side of the front strut; and c) wherein the structure describedallows for a flexing of side edges of the front shell to thereby allowthe side edges of the front shell to slip inside of outside of edges ofthe lower back shell when the front shell and the back shell are movedtowards each other to decrease the space therebetween.

In another aspect of the invention the flexible, resilient and formablematerial the interface socket is made from is polyethylene.

In yet another aspect of the invention it includes a lower socket forholding and supporting an interface socket, the lower socket consistingof: a) bottom cup; b) a front shell connected to a front top edge of thebottom cup; c) a back shell attached to the bottom cup by an articulatedadjustable strut; d) wherein the lower socket is made of a flexible,resilient and formable material; and e) wherein the front shell and theback shell form an interior space to accept an interface socket and thespace between the front shell and the back shell can be varied bymovement of the articulated strut to accommodate post-operativeinterface sockets of varying sizes.

In yet another aspect of the invention the flexible, resilient andformable material the lower socket is made from is polypropylene.

In another aspect of the invention the articulated adjustable strut ofthe lower socket is hingedly and securely connected at a first end tothe back shell and hingedly and securely connected at a second end tothe bottom cup at a position opposite the front shell.

In yet another aspect of the invention the articulated adjustable strutof the lower socket has a center plate with a first plate hingedlyattached at a first edge of the center plate and a second plate attachedat a second edge of the center opposite the first edge, wherein thefirst plate is detachably connected to the back shell and the secondplate is detachably connected to the bottom cup.

In a further aspect of the invention the back shell of the lower sockethas an upper shell detachably connects to the back shell, wherein whenthe upper shell is removed an amputee wearing the lower socket can flexthe knee of an amputated limb wearing the lower shell.

Additional features and advantages will be set forth in the detaileddescription which follows, and in part will be readily apparent to thoseskilled in the art from the description or recognized by practicing theembodiments as described in the written description and claims hereof,as well as the appended drawings:

It is to be understood that both the foregoing general description andthe following detailed description are merely exemplary, and areintended to provide an overview or framework to understand the natureand character of the claims.

The accompanying drawings are included to provide a furtherunderstanding, and are incorporated in and constitute a part of thisspecification.

The drawings illustrate one or more embodiment(s), and together with thedescription serve to explain principles and operation of the variousembodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an embodiment of the post-operative interfacesocket of the present invention;

FIG. 2 is a top view of an embodiment of the post-operative prostheticsocket with the front and rear shells spread apart;

FIG. 2A is a rear view of an embodiment of the post-operative interfacesocket showing the structure and connection of the posterior or rearstrut among other things;

FIG. 2B is a view of the front of an embodiment of the post-operativeinterface socket showing among other things the structure of the frontconnecting strut;

FIG. 2C is a view of the bottom of the post-operative interface socket;

FIG. 3 provides a front left side view of an embodiment of thepost-operative interface socket;

FIG. 3A provides a top view of an embodiment of the post-operativeinterface socket in its fully open or dilated position;

FIG. 3B provides a top view of an embodiment of the post-operativeinterface socket in its intermediate closed position;

FIG. 3C provides a top view of an embodiment of the post-operativeinterface socket in its fully constricted position;

FIG. 3D is a view of a loop connecting pad laid out;

FIG. 4 provides a side perspective view of an embodiment of thepost-operative interface socket with securing devices attached,including a loop connecting pad;;

FIG. 5 is a front left side view of an embodiment of the post-operativeinterface socket of the present invention with the upper rear shellremoved;

FIG. 6 FIG. 6 is a rear right-side view of an embodiment of thepost-operative interface socket with the upper rear shell removed;

FIG. 6A is a schematic view of the right side of an embodiment of thepost-operative interface shell of the present invention which depicts asupra condylar supra patellar (SCSP) connecting trim line;

FIG. 6B is a schematic view of the right side of an embodiment of thepost-operative interface shell of the present invention which depicts asupra condylar (SC) connecting trim line;

FIG. 6C is a schematic view of the right side of an embodiment of thepost-operative interface shell of the present invention which depicts apatellar tendon bearing (PTB) connecting trim line;

FIG. 7 is a front view perspective view of an embodiment of the outer ortower socket;

FIG. 8 is a side perspective view of an embodiment of the outer or Lowersocket of the present invention in a constricted position;

FIG. 8A is the same view as FIG. 8 but with the back shell of the lowersocket at a fully open position;

FIG. 9 is a rear perspective view of an embodiment of the outer or Lowersocket of the present invention;

FIG. 10 is a slightly raised perspective front left side view of anembodiment of the combined post-operative interface socket and tower orouter socket system as they would appear connected;

FIG. 11 is the same view as FIG. 10 with the addition of a securingpatch and an amputee's leg visible;

FIG. 12 is a left side view of an embodiment of the combinedpost-operative interface socket and lower or outer socket with the upperrear shell removed from the lower rear shell of the post-operativeinterface socket to thereby allow the knee of the amputee to flex andbend;

FIG. 13 is a side view of an alternative embodiment of the outer orlower socket of the present invention;

FIG. 14 is a is a side view or outer or lower socket depicted in FIG. 13holding the upper post-operative interface socket that does not have anupper back shell;

FIG. 15 is a side view of the lower socket of FIG. 13 holding apost-operative interface socket with an upper back shell;

FIG. 16A a top or plan view of an articulated socket attachment platesystem;

FIG. 16B a side view of an articulated socket attachment plate system;

FIG. 17A is a side raised view of the lower or outer socket with thearticulated socket attachment installed;

FIG. 17B is a back view of the lower or outer socket with thearticulated socket attachment installed; and

FIG. 17C is a side view of the lower socket and its rear shellpositioned to accommodate a reduction in size of the upper interfacesocket

FIG. 18 is a side view of a front shell of an embodiment of theinvention that has a single socket;

FIG. 19 is a side view of the rear shell of the variation of theinvention that has a single socket;

FIG. 20 is a side view of the single socket embodiment prostheticsystem;

FIG. 21 is a side view of the single socket prosthetic system showinghow the rear shell can pivot forward to accommodate changes in the sizeof the amputated limb during recovery;

FIG. 22 depicts the single socket prosthetic system with the upperportion of the rear shell removed along a trim line after post-operativerecovery to allow the amputee to flex his or her leg;

FIG. 23 depicts the single socket prosthetic system with the upperportion of the rear shell and front shell removed along another trimline after post-operative recovery to allow the amputee to flex his orher leg; and

FIG. 24 is a schematic diagram one variation of a system that useswedges to position and secure the position of the front shell and rearshell when they are connected by an articulated hinge.

DETAILED DESCRIPTION OF THE INVENTION I The Post-Operative InterfaceSocket of the Perpetual Dimension Prosthetic System

FIG. 1 provides a right side view of the post-operative interface socket310 of the present invention. This is the interface socket that anamputees' leg will be inserted into shortly after undergoing atrans-tibial amputation. It includes the upper rear shell 311 with leftside wing 314 and right side wing 315. (References to right and leftherein are from the perspective of the amputee that would be using theprosthetic device, such as the amputee would be facing in the samedirection as the front of the prosthetic apparatus faces. This isequivalent to the nautical terms of “port” for left side and “starboard”and for right side.)

The preferred embodiment of the system and apparatus of the presentinvention configures the prosthetic system for either the right or leftleg, depending on which limb has the trans-tibial amputation. Some ofthe drawings in this application depict the system and apparatusconfigured for an amputee that has undergone a trans-tibial amputationof the left leg. However, those skilled in the art will readilyunderstand that the prosthetic system and apparatus of the presentinvention can be easily configured for the right leg and that theversions for the left or right legs are essentially mirror images ofeach other.

Also, in FIG. 1 tower front shell 317 and lower back shell 319 arevisible. Upper rear shell 311 detachably connects to lower rear shell319 along line 321. At its lower end tower back shell 319 connects byposterior or rear flexible strut 323 to base 330 of bottom cup 329.Front shell 317 connects to bottom cup 329 by front strut 327. Dome 331provides space to accommodate the knee of the amputee.

As appears in FIG. 1 securing strap 339A connects by rivet 341A to theside of lower back shell 319 and a portion of securing strap 339A isvisible, it attaches by rivet 341A (not shown in this drawing) to theside of tower rear shell 319. Hook fastener patch 349A is visible onright side wing 315. Hook fastener patch 345A is visible on lower rearshell 319. The full lengths of the straps are not shown just portions ofthe straps. In the embodiment of the invention disclosed herein thesecuring and connecting mechanisms, the straps, patches etc., used are aVelcro®, like fabric hook and Loop connecting system, the hooks beingone of the connecting surfaces and the loops on another. Reference willbe made to fabric hooks and loop fasteners and will be referred to asthe hook and loop fastener or individually as hook fastener or loopfastener. Alternatively, they may be simply referred to as a securingstraps or patches. It is noted that any other type of fastener orsecuring system that can accomplish the same functions can be used.

FIG. 2 provides a view of the post-operative interface socket 310 of thepresent invention with front shell 317 and rear lower shell 319 upperrear shell 311 combination spread out for illustrative purposes. Lowerback shell 319 connects to the base 330 of bottom cup 329 by posterioror rear flexible strut 323. Front shell 317 connects to bottom cup 329by front strut 327. Dome 331 provides a space to accommodate theamputee's knee. FIG. 2 also demonstrates the fact that interface socket310 is made out of a very flexible but resilient material. In theembodiment depicted polyethylene is the preferred material, but anysimilar material that has the same qualities can be used.

FIG. 2A is a view of the posterior or rear of post-operative interfacesocket 310. Upper rear shell 311 detachably connects along line 321 tolower rear shell 319 and back rear flexible strut 323 connects lowerrear shell 319 to bottom cup 329. Hook patches 345A and 345B are visibleon lower rear shell 319. As noted, above the version of thepost-operative interface socket 310 depicted is for the left leg. Asnoted posterior or rear flexible strut 323 connects to base 330 ofbottom cup 329 at one end and it connects at its opposite end to lowerrear shell 319.

For another view we refer to FIG. 2C, a bottom view of post-operativeinterface socket 310, where open ended slots 328A and 328B eliminate theneed for strut 327 to connect to rim 329A of cup 329 and thus can bypassit and attached to bottom 330 of cup 329. By varying the length of slots328A and 328B the actual connection of strut 323 to base 330 can be madeat any selected spot. Open ended slots 328A and 328B end in circularapertures 325A and 325B. The circular apertures 325A and 325B along withslots 328A and 328B add greater flexibility to the system to vary thedistance between front shell 317 and lower rear shell 319 which will bediscussed below.

Referring back to FIG. 2A rear flexible strut 323 does not connect tothe bottom edges 336A and 336B of lower back or rear shell 319 rather asa result of open ended slots 320A and 320B strut 323 attaches further upto lower back shell 319. Here again the length of slots 320A and 320Bcan be varied to allow the actual point of connect of strut 323 to lowerrear shell 319 to be at any desired position on lower back shell 319.Open ended slots 320A and 320B end in circular apertures 322A and 322B.Additionally slots 332A and 332B separate cup 329 from bottom edges 336Aand 336B of lower back shell 319. The unique structure described aboveallows for the movement of lower back shell 319 with respect to frontshell 317 to thereby allow of the adjustment of the space between thefront shell and the lower back shell and thus accommodate amputatedlimbs of varying sizes and well as changes in the size or circumferenceof an amputee's limb that occur overtime during the recovery process aswill be discussed further below.

Referring to FIG. 2B an anterior or front view of post-operativeinterface socket 310. Front shell 317 connects by front connecting strut327 to cup 329. Front strut 327 connects front shell 317 to rim 329A ofbottom cup 329. Strut 327 is narrower than front shell 317, there beingopen ended slots 326A and 326B on either side of strut 327 that separateand create a space between rim 329A of bottom cup 329 and bottom edges316A and 316B of front shell 317. Each open ended slot 326A and 326Bterminates respectively in circular apertures 334A and 334B. Front shell317 has side edges 333A and 333B. Also, visible in FIG. 2B are sideedges 335A and 335B of lower back shell 319. As will be discussed belowgiven the structure described in this paragraph and depicted in FIG. 2Bthe side edges 333A and 333B of front shell 317 can be inserted insideof side edges of 335A and 335B of lower back shell 319 to provide anadditional means for adjusting the distance between front shell 317 andlower rear shell 319 to vary the space between them and accommodatelimbs of different size and also to accommodate changes in the size ofthe amputated limb held. One of the features of the slot structure andfront strut 327 is that it allows for the bending of edges 333A and 333Bof front shell 317 to fit inside of edges 335A and 335B to allow foradjusting the space between front shell 317 and lower rear shell 319 byallowing the front shell to slip inside of the lower rear shell.

As noted in a preferred embodiment, post-operative interface socket 310is made of polyethylene or some similar flexible but durable formablematerial. Also, in the embodiment depicted, its thickness isapproximately 2 to 3 millimeters.

FIG. 3 provides a front left side perspective view of post-operativeinterface socket 310 of the present invention. In this view straps 339Aand 339B have been secured around front shell 317. Strap 339A has beenlooped through metal loop 340A and then secured back on itself with hookand loop connectors it has on opposing surfaces. Loop 340A being securedby rivet and fabric strap 341C. Likewise strap 339B has been securedaround front shell 317. Strap 339B has been looped through loop 340B andthen secured back on itself with hook and loop connectors it has onopposing surfaces. As depicted in FIG. 2A strap 339B is connected to theback of lower rear shell 319 by rivet 341B. Referring back to FIG. 3Strap 361 is secured at one end by rivet 363B and metal and metal loop365 is at the center of strap 361. Hook securing patch 349B is on theoutside of left side wing 314 of upper rear shell 311. Hook securingpatch 345B is on lower rear shell 319. It should be noted that strap339B is covering the slots on lower rear shell 319 and front shell 317so they are not visible.

FIGS. 3A, 3B and 3C are top views of the post-operative interface socket310 that depict the variations of its interior diameter, which can varyto accommodate limbs of varying size and also adjust for swelling ordecrease in the size of a limb that normally occurs during thepost-operative recovery period.

FIG. 3A provides a top view of post-operative interface socket 310 inthe fully open position with the edges 333A and 333B of front shell 317separated from edges 335A and 335B of lower back shell 319. In FIG. 3B,the interior diameter formed by front shell 317 and lower rear shell 319is decreased and with the edges 333A and 333B of front shell 317abutting against edges 335A and 335B of front shell 317 abutting againstedges 335A and 335B of lower bottom shell 319. In FIG. 3C edges 333A and333B of front shell 317 have slipped inside of shell 319 furtherreducing the interior diameter of post-operative interface socket 310.The edges of lower rear shell 319 are not visible because they arecovered by the sides of front shell 317. Also in FIG. 3B loop securingpatch 351 has been attached to hook securing patches 349A and 349B(patches 349A and B are visible in FIGS. 1 and 3). Attaching loopsecuring patch 351 allows one to reduce the curvature of wings 315 and314 of upper rear shell 311. In FIG. 3C patch 351 has been attached andwings 315 and 314 have been further constricted, FIG. 3D provides a viewof fabric loop securing patch laid out.

FIG. 4 is a right (starboard) slightly raised side perspective view ofthe post-operative interface socket of the present invention withsecuring devices attached. Strap 339A is secured around front shell 317and loop securing patch 347 is attached to hook patches 345A and 345Bsecuring it around front shell 317. Hook patches 345A and 345B arevisible in FIGS. 1 and 3. Strap 339B is not visible since it is coveredby patch 347.

Referring to FIGS. 1, 2 and 2A connecting line 321 along which upperrear shell 311 which is a detachable connection to lower rear shell 319is in effect a trim line. The type of trim line depicted in FIG. 5 andFIG. 6 after upper rear shell 311 is removed is a supra condylar suprapatellar (SCSP) trim line. Note that upon removal of upper rear shell311 the interface socket is identified by reference number 310A in thisspecification. However, the trim line can be varied depending on theneeds of the particular amputee. FIGS. 6A, 6B and 6C provide a schematicdiagram of some of the various trim lines that can be achieved with thepresent invention. In FIGS. 6A, 6B and 6C the hatched area in eachfigure is the portion of post-operative interface shell 310 namely upperrear shell 311 that is removed after the amputee's leg has sufficientlyhealed such that the leg and specifically the knee no longer needs to beimmobilized and it becomes interface socket 310A.

FIG. 6A is an SCSP trim line wherein upper rear shell 311 is removedalong SCSP trim line 321. As can be seen only upper rear shell 311 isremoved. FIG. 6B depicts a supra condylar (SC) trim line 321A whereinnot only is rear shell 311 detached along line 321A but trim line 321Acontinues along the top of front shell which is also removed. FIG. 6Cshows a patellar tendon bearing (PTB) trim line 321B where upper rearshell 311 is detached from lower rear shell 319 along line 321B, andtrim line 321B continues along front shell 317 to thereby remove asignificant portion of front shell at and below where the knee of theamputee would be when the amputee is wearing the post-operativeinterface socket 310A.

As demonstrated in FIGS. 3A, 3B and 3C above by use of straps 339A and339B the interior diameter of post-operative interface socket 310 can bevaried as depicted in FIGS. 3A, 3B, and 3C. By placing security hookfastener patch 347 around front shell 317 connected to patches 345A and345B, this provides an additional means for securing a desired orrequired inner space in post-operative interface socket 310 and toadjust it to the varying size of the post-operative trans-tibialamputated limb.

The ability to vary the interior circumference of post-operativeinterface socket 310 and likewise 310A, after removal of upper shell311, provides a number of advantages. First, it reduces the number ofsizes of post-operative interface sockets 310 that need to be maintainedin stock to accommodate amputee limbs of varying size. The flexibilityin sizing described above increases the dimensional range of theanterior-posterior (AP) range and medial-lateral (ML) and circumferencesfrom 4″ to 6″ depending on the size of the patient. Additionally, thecircumference of the portion of amputated limb will vary significantlyfrom the time of the operation amputating the lower limb to the time theamputee is able to walk normally. Right after the operation, the limbwill typically swell due to the trauma of the surgery. While recoveringfrom the operation and healing, the amputee's limb will shrink indiameter as part of the healing process as well as the relativeinactivity imposed on it. This is in part due to the need to keep theknee immobilized during the initial recovery phase. Post-operativeinterface socket 310 can be easily adjusted by straps 339A and 339B andpatch 347.

Once the initial healing process is complete and the patient can startflexing their knee, there is no need to switch to another interfacesocket. As depicted in FIG. 5, upper back or rear shell 311 is detachedfrom lower back shell 319 along line 321. This then allows the amputeeto continue to use post-operative interface socket 310A and start toflex his or her knee. Upper back shell 311 when attached to lower backshell 319 is designed to immobilize the limb and prevent flexing of theknee to aid in the initial heating process. However, once the healingprocess has progressed sufficiently the amputee needs to start flexingthe knee to begin the process of starting to walk and move normally.FIG. 6 provides a rear view of post-operative interface socket 310A withupper rear shell removed so the amputee can flex their knee and bendtheir leg.

II The Outer or Lower Socket of the Perpetual Dimension ProstheticSystem

Outer or lower socket 410 is depicted in FIGS. 7, 8 and 9 in a frontview, side view and rear view respectively. In a preferred embodimentpolypropylene is the preferred material for outer socket 410. Itprovides a flexible, sturdy, resilient, formable and lightweightmaterial. In the embodiment shown the thickness of the material is about4 to 5 millimeters.

The parts visible in FIG. 7 include front shell 411, which attaches tobase or bottom cup 415. Front shell 411 has a left wing 416 and a rightwing 418. (As noted previously references to right and left herein arefrom the perspective of the amputee that would be using the prostheticdevice, such as the direction the front of the object described faces.This is then equivalent to the nautical terms of “port” and“starboard”.) Strap 429 connects to wing 418 by rivet 431B and to wing416 by rivet 431A. Retention ring 433 is attached to the center of strap429. Attached to the bottom receiving plate 442 which forms a reinforcedbase of bottom cup 415 is hardware connecting device 443, shaft 441 andartificial foot 445. In a standard fashion bolts, not shown would passup through hard connecting device 443, through receiving plate 442 andconnect to a retention bracket on the inside of bottom of outer socket410. Shaft 441 securely attaches in a standard fashion to connectinghardware device 443. The connection created is strong enough to bear theweight and stress and strain of an adult waking the prosthetic system.Artificial foot 445 completes the system.

FIG. 8 provides a side view of lower or outer socket 410. In this sideview additional parts of outer or lower shell are visible, namely backshell 417 and articulated strut 419 that connects to back shell 417 atflex line 421A and to base cup 415 at flex line 421B. Securing straps423A and 423B connect around front shell 411 and hold back shell 417 inposition.

FIG. 9 is a rear view of outer socket 410 without items 443, 441 and 445attached. Additional aspects of lower socket 410 visible are flex lines421A and 421B that allow articulate strut 419 to move back and forth.Rivet 427A holds strap 423A to back shell 417 and rivet 427B holds strap423B to back shell 417. Rivet 424A holds metal loop and retention strap425A and rivet 424B holds metal loop and retention strap 425B to backshell 417.

Flex lines 421A and 421B in the embodiment depicted in FIG. 9 arecreated by compressing the material which lower socket 410 is made of,in the embodiment depicted polypropylene. Flex lines 421A and 421B bymovement of articulated strut 419 allow back shell 417 to be movedbetween the positions depicted in FIG. 8 and FIG. 8A and thus allowouter socket to adjust to the varying circumferential sizes thepost-operative interface socket 310 will varying given the different inlimb sizes of amputees and the variation of a particular amputees limbthat occurs during the heating and recovery process.

FIG. 16A depicts another variation of the articulated and movable strut(419 depicted in FIGS. 8, 8A and 9). In the variation depicted in FIG.16A is a separate double hinged socket attachment plate 711. Hingedsocket attachment 711 is made up of a lower plate 711A, a middle plate711B, and an upper plate 711C. Lower plate 711A connects to middle plate711B by hinge 715B. Middle plate 711B connects to upper plate 711C byhinge 715A. Referring now to FIG. 16B a side view of articulated socketattachment plate 711. As depicted in FIG. 16B, both hinges 715A and 715Bare fully articulated allowing the plates to be freely moved withrespect to each other. As depicted plate 711C can be pivoted on hinge715A with respect to plate 711B in the direction of arrows 721A and721B. Likewise, plate 711B can be pivoted on hinge 715B with respect toits orientation to plate 711A in the direction of arrows 723A and 723B.Plate 711 can be fabricated from any number of rigid but durablematerials including aluminum, polypropylene, polyethylene, stainlesssteel, etc. Screw holes 717 on plate 711A and screw holes 719 on plate711C provide means for attaching articulated socket attachment 711 tothe base cup and the back shell of the outer or lower socket, as will bedescribed below.

Referring now to FIG. 17A a side raised view of the lower or outersocket 710 with articulated socket plate system 711 attached to thelower or outer socket. As depicted, lower socket attachment plate 711Ais attached to the top inside of base cup 725 of the lower socket. Plate711A is attached in the standard fashion with screws inserted throughscrew holes 717. Plate 711C is attached to back shell 727, as depicted,in the standard fashion by inserting screws through screw holes 719. Inthis variation of the lower socket back shell is separate from the restof the lower socket and only connected by the articulated socketattachment plate 711.

FIG. 17B is a rear view of tower socket 710 with articulated platesystem 711 attached. As can be seen, back shell 727 is not directlyattached to lower cup 725. Rather, articulated plate system 711Bconnects lower cup 725 to back shell 727. This is to allow for movementof back shell 727 to vary the size of space lower socket 710 provides.It thus serves the same function as articulated strut 417. FIGS. 8 and8A show how articulated strut 417 allows for the varying of the distancebetween back shell 417 and the front of lower socket 410. FIG. 17Cdepicts how rear shell 727 can be moved forward by adjusting plates 711Cand 711B with respect to 711A. This thus allows lower socket 710 toaccommodate the varying size of the upper interface socket 310 as thetrans-tibial amputee proceeds through the recovery process.

III The Overall Combined Post-Operative Lower Socket Perpetual DimensionProsthetic System

FIG. 10 provides a front left side prospective view of the parts of theprosthetic system 501 of the present invention namely post-operativeinterface socket 310 as it is used with outer lower socket 410.Post-operative interface socket 310 is positioned inside of outer socket410 with shaft 441 and artificial foot 445 attached in a configurationready for a trans-tibial amputee to use. FIG. 11 provides a front leftside perspective view of the prosthetic system 501 of the presentinvention as it might appear on an amputee's leg 531. The limb 531 of anamputee can be seen and loop patch 351 has been attached to hook pads349A and 349B. AS depicted in FIG. 11 upper rear shell 311 immobilizesthe limb 531 and prevents it from flexing at the knee. However, aspictured in FIG. 12, a rear left side view of the entire prostheticsystem 501, upper rear shell 311 has been removed to allow limb 531 toflex at the knee as depicted therein.

FIG. 13 provides a side view of an alternative version of the towersocket 611. In this variation of the invention lower socket 611 has adetachable upper back shell 615 detachable along line 617. Detachableupper back shell 615 has the same purpose as the detachable upper backshell 311 of the upper or interface socket 310, FIG. 1. Referring backto FIG. 13 upper back shell 615 of lower socket 611 is also designed toimmobilize the trans tribal leg amputee's and prevent flexing of theknee during the initial heating process after the amputation. As notedpreviously the knee of the amputee needs for a period of time after theamputation to recover from the trauma of the operation.

FIG. 14 provides a side view of lower shell 611 of lower socket 611holding post-operative interface socket 310A. In this variation depictedupper back shell 615 of lower socket 611 takes the place of upper rearshell 311 of interface socket 310. Once the amputee has sufficientlyrecovered upper shell 615 is removed along line 617. Once this uppershell 615 is removed the amputee then can flex his or her knee asdepicted in FIG. 12.

FIG. 15 provides another variation of the invention where upper orpost-operative interface socket 310 with upper back shell 311 is usedwith lower socket 611. In this variation both upper rear or back shell311 of interface socket 310 and upper shell 615 of lower socket 611 helpimmobilize the knee of the amputee during the initial healing process.Thus once the healing process is complete both shell 311 and 615 can beremoved to allow the amputee to flex his or her knee.

IV An Alternative Single Socket Post-Operative Perpetual DimensionProsthetic System

In another embodiment of the invention the prosthetic system consists ofa single socket. In this embodiment it has a front shell 801 FIG. 18.Front shell 801 has an extended surface 801A that is shaped to fitagainst the front of a trans-tibial amputee's leg or limb. Extendedsurface 801A of the front shell terminates in a base 801B that will bebelow the bottom of the amputee's limb. Dome 831 provides room toaccommodate the amputee's knee. As will be discussed below, since frontshell 801 will be the main weight bearing part of the single socketsystem it must be made of a semi rigid load bearing material. In thepreferred embodiment polypropylene is used to make front shell 801.Polypropylene is easy to work with and form into the desired shape andis strong enough to bear the full Load of an amputee's body when walkingor running.

FIG. 19 is a side view of an embodiment of the rear shell 803 of thesingle socket prosthesis of the present invention. As can be seen rearshell 803 has an extended surface configured to fit against the rear ofthe leg of an amputee. Rear shell 803 is made of a pliable and formablematerial. In the preferred embodiment it is made of polyethylene.

The front shell and rear shell are attached by articulated hinge 711FIGS. 16A and 16B. Referring now to FIG. 20 which provides a side viewof the single socket embodiment 800 of the invention fully assembled. Itincludes front shell 801 connected to the rear shell 803 by hinge 711shown in outline since it is inside the shells. Plate 711A attaches to atop inside surface of base 801B and plate 711C attaches to a bottom edgeof rear shell 803. Center plate 711B of articulated hinge 711 onlyconnects at pivot points with plates 711A and 711C and thus can movewhen plates 711A or 711C move.

Foot 445 is connected by shaft 441 to hardware 443 and reinforced bottomconnection plate 442 of front shell 801. Reinforced connection plate 442is a reinforced portion of front shell 801 capable of carrying the loadput on it by the amputee when waling or standing.

FIG. 21 shows how the space between the front shell 801 and the rearshell 803 can be varied by articulated hinge 711. As noted above sinceplate 711B of hinge 711 is only hingedly connected to plates 711A and711C it can move to allow shell move with respect to shell 801 andchange the space between the two shells. As noted previously after anamputation of a limb, the remaining portion of the amputated limb variesin size over the course of the amputee's recovery from the surgery.Initially it will swell as a result of the trauma of the surgery.Subsequently it will also shrink as the patient recovers. It will shrinkas a result of the need to minimize use of the limb during recovery. InParticular with a post-operative transitional amputation this includesimmobilizing the knee of the amputee until the surgical wound created bythe surgery has fully healed.

Referring to FIGS. 22 and 23 once the amputee has recovered from theoperation and can begin exercising his or her leg the upper portion 805of the rear shell 803 can be removed to allow the amputee to flex his orher leg 807 and bend the knee and begin therapy to walk in a normalfashion. Additionally, parts of upper portions 801C of the front shellcan also be removed. As previously discussed above with respect to thetwo socket version of the invention the shells can be cut alongdifferent trim lines three of which are: 1) Supra Condylar SupraPatellar (SCSP) trim line, 2) super condylar (SC) trim line and 3)Patellar tendon bearing (PTB) trim line (FIGS. 6A, 6B and 6C). Referringback to FIG. 22 it provides an example of a SCSP trim line cut 817 ofthe single socket system. Likewise FIG. 23 is an example of PTB trimline cut 819. Naturally, the trim line cut can be varied significantlyto achieve optimal movement and support which can include a supercondylar (SC) as depicted in FIG. 6B. Thus, any number of variations ofcuts can be made depending on the needs of the particular amputee. Asdepicted in FIGS. 22 and 23 once the trim line cut is made it allows theamputee to move his limb 807 and flex his or her knee 809.

V. An Apparatus for Dimensional Changes of the Socket

In another aspect of the invention it includes an apparatus forpositioning and fixing the dimensional changes of the space between thefront and back shells of the sockets that are connected by anarticulated hinge. Referring to FIG. 21 as depicted therein two spacingand positioning wedges 821A and 821B are positioned between center plate711 of articulated hinged 711 and the back rim 801D of base 801B offront shell 801.

By varying the number of wedges from none to 3, the position of centerplate 711B can be fixed. FIG. 24 provides a schematic of the wedgepositioning system of the present invention. Articulated hinge 711connects by plate 711C to a lower portion 803A of rear shell 803. Plate711A of hinge 711 connects to the inside of bottom base 801B of thefront shell Rear rim 801. Spacing wedges 821A, 821B, and 821C aredepicted in a semi-exploded view are positioned between rear rim 801D ofbase 801B of front shell 801 and center hinge plate 711B. In theembodiment depicted in FIG. 24, wedge 821A connects to rear rim 801D byretaining screw 841. Wedge 821C connects to center hinge plate 711B byretaining screw 843. Wedge 821B has knob 845 which fits into recess 846.Wedge 821C has knob 847 which fits into recess 848 of wedge. Thus, whenwedges 821A, 821B, and 821C are inserted and connected together they areheld in place.

It will be apparent to those skilled in the art that variousmodifications and variations can be made without departing from thespirit or scope of the invention. Since modifications combinations,sub-combinations and variations of the disclosed embodimentsincorporating the spirit and substance of the invention may occur topersons skilled in the art, the invention should be construed to includeeverything within the scope of the appended claims and theirequivalents.

What is claimed is:
 1. A single socket adjustable prosthetic systemcomprising: a) a first shell with an extended surface configured to fitagainst a first side of an amputee's limb, which surface terminates atits bottom in a base, said base configured to extend under the amputee'slimb; b) a second shell with an extended surface configured to fitagainst a second side of the amputee's limb; and c) an articulated hingeconnected at a first end to said first shell at said base of said firstshell and said articulated hinge is connected at a second end to a loweredge of said second shell to thereby allow a space between said firstshell and said second shell to be varied to accommodate swelling andshrinking of the amputees limb and hold said limb securely andcomfortably.
 2. The single socket adjustable prosthetic system of claim1 wherein: a) said first shell is made of a semi rigid load bearingmaterial and said bottom base is wide and wherein when said first end ofsaid articulated hinge attaches to said base at an interior top surfaceof said base of said first shell; b) a shaft connects at a top end to anoutside bottom surface of said wide bottom base of said first shell andprojects downwards from said base; c) a prosthetic foot attaches to abottom end of said shaft; d) said second shell is made of a pliable andformable material; and e) wherein when said system is attached to aremaining portion of a limb of the amputee said amputee can use saidlimb to stand and for mobility.
 3. The single socket adjustableprosthetic system of claim 1 wherein: a) said articulated hinge hasthree plates, a center plate with a first end plate hingedly attached atsaid first end of said center plate and a second plate hingedly attachedat said second end of said center plate; and b) wherein said first plateof said articulated hinge attaches to said interior base of said firstshell and said second plate of said articulated hinge attaches at alower interior end of said second shell.
 4. The single socket adjustableprosthetic system of claim 1 wherein said semi rigid load bearingmaterial said first shell is made of is polypropylene and said pliableand formable material said second shell is made from is polyethylene. 5.The single socket adjustable prosthetic system of claim 1 wherein: a)the amputee has had a trans-tibial amputation and the first side of theamputee's limb is the front of the limb and the second side of theamputee's limb is the rear of the limb; b) said second shell has anupper portion such that when said single socket is attached to theamputee's leg it prevents the amputee from bending of the knee of theamputee; c) said first shell has an upper portion that covers andprotects the knee of the amputee; and d) a trim line can be cut thatremoves portions of the upper portion of the second shell and can removeportions of said upper portion of said first shell, to thereby allow theamputee to flex the knee when said single socket is attached to theamputee's leg.
 6. The single socket adjustable prosthetic system ofclaim of claim 5 wherein the trim line cut of said upper portion of saidsecond shell and said first shell is selected from the group consistingof: a supra condylar supra patellar (SCSP) trim line, a supra condylar(SC) trim line, and a patellar tendon bearing (PTB) trim line.
 7. Thesingle socket adjustable prosthetic system of claim 3 further comprisinga hinge positioning and securing system wherein: a) said base of saidfirst shell has a rim around a rear portion of said base opposite theconnection of said extended surfaces connection to said base; b) saidhinged attachment of said first plate to said center plate is positionedat the base of said rim when said first plate is connected to saidinterior of said base; and c) said center plate can be positioned atdifferent positions from said rim by insertion of at least one wedgebetween said center plate and said rim.